850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).

Other Names:

Fortamet

Glucophage

Glumetza

Riomet

Detailed Description:

This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Be between the ages of 18-75 years old

Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy

Have no contraindications to short-term metformin therapy

Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula

Have normal serum transaminase values (AST and ALT)

Need to be able to undergo metformin treatment for a duration of 12 weeks prior to repeat endometrial biopsy

Exclusion Criteria:

Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin

Have a history of liver or renal dysfunction.

Have a random glucose of ≤ 65 or ≥ 200

Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study.

Have a history of vitamin B12 deficiency

Are pregnant

Are currently taking insulin

Are taking a drug that may significantly interact or influence the metabolism of metformin

In the opinion of the investigator, the patient is felt not to be appropriate for the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685762